Device product
Bard TruGuide Disposable Coaxial Biopsy Needle Mixed Product Part Number C1816B The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.
Z-2547-2016
Product summary
- Event
- Event 74663
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1250 units
- Official record key
device-enforcement:Z-2547-2016
Official wording
Reason: May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.
Code information: Lot Number: REZK0479
Distribution pattern: Nationwide Distribution to the following; CA, LA, VA, IA, AR, SC, PA, MA, IL, MO. Foreign distribution to the following; Canada, Belgium, Australia, Taiwan, China, Argentina.
Derived failure modes
-
Unknown
May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.